Zelsuvmi FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 9, 2024.
FDA Approved: Yes (First approved January 5, 2024)
Brand name: Zelsuvmi
Generic name: berdazimer sodium
Dosage form: Topical Gel
Company: Ligand Pharmaceuticals
Treatment for: Molluscum Contagiosum
Zelsuvmi (berdazimer sodium) is a nitric oxide-releasing agent indicated for the topical treatment of molluscum contagiosum (MC) in adults and pediatric patients 1 year of age and older.
- Molluscum contagiosum is a common, contagious viral skin infection caused by the molluscipoxvirus. It is characterized by small, raised lesions called Mollusca that may appear anywhere on the body.
- Zelsuvmi gel contains berdazimer which acts as an antiviral to clear molluscum lesions. It works by releasing nitric oxide which has regulatory functions that affect NF-κB, immunomodulation, inflammation, cytokine production, and apoptosis likely through S-nitrosylation of proteins. Nitric oxide also has cytotoxic functions that affect viral replication through reactive oxygen and/or nitrogen molecules.
- FDA approval of Zelsuvmi was based on the results the B-SIMPLE 4 and B-SIMPLE 2 Phase 3 trials which demonstrated a reduction in lesion counts, and also showed that the treatment was well tolerated when used once a day.
- Zelsuvmi is administered once daily to each molluscum contagiosum lesion for up to 12 weeks. Zelsuvmi is supplied as two tubes containing berdazimer gel and hydrogel, which are mixed together immediately prior to application.
- Warnings and precautions associated with Zelsuvmi include application site reactions.
- Common adverse reactions include application site reactions such as painful burning or stinging sensations, erythema, pruritus, exfoliation, dermatitis, swelling, erosion, discoloration, vesicles, irritation, and infection.
Development timeline for Zelsuvmi
Further information
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